Guidance document - Safety and effectiveness requirements for high-level disinfectants and sterilants for use on reusable semi-critical and critical medical devices (2018)

Guidance document - Safety and effectiveness requirements for high-level disinfectants and sterilants for use on reusable semi-critical and critical medical devices (2018) This guidance document outlines the information considered necessary to support the safety and effectiveness of chemical products that are represented for use as high-level disinfectants and sterilants on reusable semi-critical and critical medical devices, which are regulated as medical devices under the Medical Devices Regulations. 2021-07-06 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGuidance documentsafety and effectiveness requirementshigh-level disinfectants and sterilantsreusablesemi-criticalcriticalmedical devicessafety and effectiveness of chemical productsreusable semi-criticalcritical medical devices Guidance document - Safety and effectiveness requirements for high-level disinfectants and sterilants for use on reusable semi-critical and critical medical devices (2018)HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/disinfectants/safety-efficacy-requirements-high-level-disinfectants-sterilants-use-reusable-semi-critical-critical-medical-devices.html#a1 Guidance document - Safety and effectiveness requirements for high-level disinfectants and sterilants for use on reusable semi-critical and critical medical devices (2018)HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/desinfectants/exigences-matiere-innocuite-efficacite-relatives-desinfectants-haut-niveau-agents-sterilisateurs-destines-instruments-medicaux.html#a1

This guidance document outlines the information considered necessary to support the safety and effectiveness of chemical products that are represented for use as high-level disinfectants and sterilants on reusable semi-critical and critical medical devices, which are regulated as medical devices under the Medical Devices Regulations.

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